The present invention relates in general to a system and method in the field of prolapse treatment. More particularly, the present invention relates to a system with multiple components, and a method for surgically correcting tissue wall prolapse using the same. Specifically, a preferred embodiment of the present invention is a kit that has the following components: a precut shaped mesh graft and a graft delivery device.
As is known to those skilled in the art, the treatment of vaginal wall prolapse has been hampered by high failure rates. The main reasons for failure have been the inherent weakness of the tissue being re-approximated and the inability of the repaired tissue to withstand the forces applied by the abdominal cavity bearing down from above. In the last decade, one major advance has been the addition of grafts to reinforce those repairs. While this phenomenon has been gaining widespread acceptance, there lacks a consensus regarding how to affix the graft under the vaginal wall to best maintain durability and vaginal caliber.
A number of prior art patents and publications are directed to various methods of treating and preventing recurring vaginal wall prolapse. For instance, U.S. Pat. No. 6,102,921 (the “'921 patent”), incorporated herein by reference, discloses a mesh graft material for treating vaginal prolapse. Further, U.S. Pat. No. 6,638,284 discloses an apparatus configured for delivering a mesh graft like that of the '921 patent for treating vaginal wall prolapse.
The most commonly accepted procedure for surgical treatment of pelvic organ prolapse is an abdominal sacrocolopopexy (ASC). The procedure was originally described as being performed through an open incision, i.e., laparotomy, wherein one end of a wide graft was attached to the vagina with multiple sutures and the other end attached to the sacral promontory after opening the enclosing tissue layer known as the peritoneum. The procedure has been refined over the years and has multiple subtle variations. It is acknowledged that the procedure, as described, has several limitations and, as such, the procedure is not utilized by all surgeons despite its overall level of success as compared to other treatments. For example, opening the peritoneum and sewing within the retroperitoneal space requires special skill and there is significant risk of bleeding. In addition, it is particularly challenging to apply the correct amount of tension to the graft needed to elevate the vagina and then fixate the graft at that tension.
Further, this approach has been associated with an increased risk of serious bowel complications, including potentially life threatening bowel obstruction. To avoid these complications, some surgeons have begun to attempt this procedure laparoscopically, at times employing known robotic techniques. However, this also creates a number of technical challenges as laparoscopic knot tying is a skill possessed by only a limited number of surgeons.
One alternative treatment approach for prolapse has been to introduce the mesh transvaginally. The evolution of transvaginal mesh procedures has produced several deployment devices to increase safety and make the procedures accessible to more surgeons. One procedure includes the use of a Pinnacle® device, made by Boston Scientific Corporation, having a dilator for bringing the mesh into place along with a limited access suture capture device (known commercially as a Capio®, made by Boston Scientific Corporation). However, some surgeons prefer to not introduce the mesh directly through the vagina due to potential inherent infectious and sexual complications associated with transvaginal introduction. PCT publication WO/20071109508 discloses a method and system for treating vaginal wall prolapse by transvaginal insertion of a mesh graft, and is herein incorporated by reference.
Accordingly, it has been desired to provide a device and method of treating vaginal prolapse that combines the ease of use of the transvaginal meshes, and in particular, leveraging a suture capture device and Pinnacle®-like dilators to employ the mesh laparoscopically, with the known advantages of the ASC procedure, i.e., ease of reaching internal structures necessary for implementing the mesh. Enhancements to the shape of the graft and the method of attachment to both the vagina and the sacrum provide increased safety and ease of use. The present invention eliminates the need to suture the graft to the sacrum. These enhancements thereby allow a greater number of patients to be treated using a minimally invasive prolapse treatment.